Back to resultsLoiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Primary Purpose
Loiasis
Status
Completed
Phase
Phase 4
Locations
Cameroon
Study Type
Interventional
Intervention
Ivermectin
Sponsored by
About this trial
This is an interventional basic science trial for Loiasis
Eligibility Criteria
Inclusion Criteria:
- Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Exclusion Criteria:
- known allergy to ivermectin; severe comorbidities
Sites / Locations
- Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ivermectin
Arm Description
All eligible participants received a single dose (150 ug/kg) ivermectin by mouth
Outcomes
Primary Outcome Measures
Cross-reactive Antigenemia
N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05085665
First Posted
October 7, 2021
Last Updated
August 30, 2022
Sponsor
Washington University School of Medicine
Collaborators
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
1. Study Identification
Unique Protocol Identification Number
NCT05085665
Brief Title
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Official Title
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Center for Research on Filariasis and Other Tropical Diseases, Cameroon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
Detailed Description
A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loiasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ivermectin
Arm Type
Experimental
Arm Description
All eligible participants received a single dose (150 ug/kg) ivermectin by mouth
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
single dose, 150 ug/kg
Primary Outcome Measure Information:
Title
Cross-reactive Antigenemia
Description
N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Exclusion Criteria:
known allergy to ivermectin; severe comorbidities
Facility Information:
Facility Name
Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)
City
Yaoundé
Country
Cameroon
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
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